Regulatory Watch - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Regulatory Watch

Tackling Drug Shortages

November 2, 2014

Pharmaceutical Technology

Resolving the problem will require more communication between the industry and regulatory bodies.

New Era for Generic Drugs

November 2, 2014

Pharmaceutical Technology

Manufacturers face regulatory overhaul, while brand-generic debates escalate over biosimilars and labeling changes.

Harmonizing Marketing Approval of Generic Drugs in Europe

October 2, 2014

Pharmaceutical Technology

Regulatory agencies in Europe are working to harmonize the marketing approval pathway of generic medicines.

Biopharma Manufacturers Respond to Ebola Crisis

October 2, 2014

Pharmaceutical Technology

Demand for new therapies and vaccines spotlights production challenges.

Extending the Scope of Pharmacovigilance Comes at a Price

September 2, 2014

Pharmaceutical Technology

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Data Integrity Key to GMP Compliance

September 2, 2014

Pharmaceutical Technology

FDA demands accurate manufacturing and test information to ensure product quality.

Changes and Challenges for Generic Drugs

August 2, 2014

Pharmaceutical Technology

FDA seeks high quality applications and products to facilitate approvals and reduce safety and supply problems.

Industry Seeks Clearer Standards for Track and Trace

July 2, 2014

Pharmaceutical Technology

Stakeholders face challenges and benefits from a more secure pharmaceutical supply chain.

Global Expansion Shapes Drug Oversight

June 2, 2014

Pharmaceutical Technology

Regulators and industry organizations explain policies and standards to manufacturers and authorities in all regions.

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What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
23%
Oversee medical treatment of patients in the US.
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All of the above.
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Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
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